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TAME Health: Testing Activity Monitors' Effect on Health

TAME Health: Testing Activity Monitors' Effect on Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02554435
Enrollment
40
Registered
2015-09-18
Start date
2016-01-31
Completion date
2016-09-30
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

physical activity, activity monitor, older adults, 5 A's counseling

Brief summary

Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.

Detailed description

Cardiovascular disease (CVD) is prevalent and the leading cause for mortality in the United States. The American Heart Association's (AHA) 2020 Impact Goal is to improve the cardiovascular health of all Americans by 20 percent while reducing deaths from CVD and stroke by 20 percent. Maintaining healthy levels of physical activity (PA) is critical in maintaining cardiovascular health, but older adults are inactive. Inactivity may be influenced by low levels of motivation. Standard behavioral counseling techniques typically implemented within the primary care setting target increased motivation, but lack the key component of self-control. The addition of electronic activity monitors (EAMs) that provide interactive self-monitoring, feedback, and social support may further increase motivation for exercise by providing more effective behavior change techniques than standard protocols. Investigators will conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (N = 40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Investigators propose two Specific Aims: AIM 1: Evaluate the feasibility and acceptability of implementing a technology-enhanced brief intervention to increase physical activity in a primary care setting. Measures of feasibility will include days the EAM was worn, usage of the app, technological problems, attrition, and adverse events. Acceptability will be measured by self-report and focus groups. AIM 2: Compare the counseling plus EAM intervention to a counseling plus pedometer intervention. Primary outcomes will be changes in PA and cardiovascular risk. We will also investigate secondary outcomes (differences in adherence, weight and body composition, health status, motivation, physical function, psychological feelings, self-regulation).

Interventions

DEVICEEAM

The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.

BEHAVIORAL5 A's counseling

Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.

DEVICEPedometer

The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.

Sponsors

American Heart Association
CollaboratorOTHER
The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

* physically inactive (less than 60 minutes per week) * BMI between 25-35 * in good health measured by Par-Q+ * access to a smart phone

Exclusion criteria

* physical activity is inadvisable by their doctor * involved in another physical activity intervention within the past 6 months * used an activity monitor in the past 6 months * unwilling to travel for scheduled visits * currently taking medications that affect body composition * current smoker * report alcohol or drug problem * institutionalized for psychiatric illness within the last year * do not consent

Design outcomes

Primary

MeasureTime frameDescription
Physical Activity Minutes Measured by a SenseWear ArmbandPhysical activity minutes at the end of the 12 week interventionMinutes of moderate-vigorous physical activity over a 7 day period
Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk CalculatorCardiovascular risk at the end of the 12 week interventionFactors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to \>30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to \>30% risk of a cardiovascular event within the next 10 years.
6-minute Walk TestFitness at the end of the 12 week interventiondistance walked in 6 minutes
Steps Per DaySteps per day at the end of the 12 week interventionMeasured by a SenseWear Armband. Average steps per day over a 7 day period

Secondary

MeasureTime frameDescription
Exercise MotivationExercise motivation at the end of the 12 week interventionMeasured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of intrinsic and identified are better. Alternatively, low scores of introjected, extrinsic, and amotivation are better.
Quality of Life Measured by the SF-36 QuestionnaireQuality of life at the end of the 12 week interventionSub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale.
Physical Function Measured by the Short Physical Performance BatteryPhysical function at the end of the 12 week interventionPhysical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled tandem balance.
WeightWeight at the end of the 12 week intervention
Resting PulseResting pulse at the end of the 12 week intervention
Change From Baseline in Self-regulationChange in self-regulation from baseline and 12-weeksMeasured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.
Psychological FeelingsPsychological feelings at the end of the 12 week interventionMeasured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.
Body Mass Index (BMI)BMI at the end of the 12 week intervention
Waist-to-Hip RatioWaist-to-hip ratio at the end of the 12 week interventionWaist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).
Blood PressureBlood pressure at the end of the 12 week intervention

Countries

United States

Participant flow

Participants by arm

ArmCount
Pedometer
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary. 5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange. Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
20
Electronic Activity Monitor
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will friend other participants to utilize these features. EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app. 5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
20
Total40

Baseline characteristics

CharacteristicPedometerElectronic Activity MonitorTotal
Age, Continuous63.2 years
STANDARD_DEVIATION 5.7
64.0 years
STANDARD_DEVIATION 5.1
63.7 years
STANDARD_DEVIATION 5.3
Physical Activity40.0 minutes per day
STANDARD_DEVIATION 33.9
22.5 minutes per day
STANDARD_DEVIATION 21.5
31.3 minutes per day
STANDARD_DEVIATION 29.4
Race/Ethnicity, Customized
Black/African-American
3 Participants4 Participants7 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants3 Participants5 Participants
Race/Ethnicity, Customized
Non-Hispanic White
14 Participants12 Participants26 Participants
Race/Ethnicity, Customized
Other
1 Participants1 Participants2 Participants
Sex: Female, Male
Female
13 Participants17 Participants30 Participants
Sex: Female, Male
Male
7 Participants3 Participants10 Participants
Steps4560.18 steps per day
STANDARD_DEVIATION 2285.6
3849.4 steps per day
STANDARD_DEVIATION 2107.8
4204.8 steps per day
STANDARD_DEVIATION 2199.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 203 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

6-minute Walk Test

distance walked in 6 minutes

Time frame: Fitness at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
Pedometer6-minute Walk Test1642.9 feetStandard Deviation 287.3
Electronic Activity Monitor6-minute Walk Test1561 feetStandard Deviation 353.6
Primary

Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator

Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to \>30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to \>30% risk of a cardiovascular event within the next 10 years.

Time frame: Cardiovascular risk at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
PedometerComposite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator21.2 Risk scoreStandard Deviation 12.6
Electronic Activity MonitorComposite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator16.6 Risk scoreStandard Deviation 13.2
Primary

Physical Activity Minutes Measured by a SenseWear Armband

Minutes of moderate-vigorous physical activity over a 7 day period

Time frame: Physical activity minutes at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
PedometerPhysical Activity Minutes Measured by a SenseWear Armband40.2 minutes per dayStandard Deviation 3.7
Electronic Activity MonitorPhysical Activity Minutes Measured by a SenseWear Armband33.8 minutes per dayStandard Deviation 27.6
Primary

Steps Per Day

Measured by a SenseWear Armband. Average steps per day over a 7 day period

Time frame: Steps per day at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
PedometerSteps Per Day4702 stepsStandard Deviation 2259.7
Electronic Activity MonitorSteps Per Day4353 stepsStandard Deviation 2021.4
Secondary

Blood Pressure

Time frame: Blood pressure at the end of the 12 week intervention

ArmMeasureGroupValue (MEAN)Dispersion
PedometerBlood PressureDiastolic blood pressure83.4 mmHgStandard Deviation 10
PedometerBlood PressureSystolic blood pressure134.3 mmHgStandard Deviation 14.6
Electronic Activity MonitorBlood PressureSystolic blood pressure125.0 mmHgStandard Deviation 14.5
Electronic Activity MonitorBlood PressureDiastolic blood pressure80 mmHgStandard Deviation 9.8
Secondary

Body Mass Index (BMI)

Time frame: BMI at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
PedometerBody Mass Index (BMI)30.5 kg/m^2Standard Deviation 3.1
Electronic Activity MonitorBody Mass Index (BMI)30.0 kg/m^2Standard Deviation 3.5
Secondary

Change From Baseline in Self-regulation

Measured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.

Time frame: Change in self-regulation from baseline and 12-weeks

ArmMeasureGroupValue (MEAN)Dispersion
PedometerChange From Baseline in Self-regulationGoal-setting22.1 units on a scaleStandard Deviation 5.3
PedometerChange From Baseline in Self-regulationPlanning24.3 units on a scaleStandard Deviation 4.1
Electronic Activity MonitorChange From Baseline in Self-regulationGoal-setting31.3 units on a scaleStandard Deviation 9.8
Electronic Activity MonitorChange From Baseline in Self-regulationPlanning26.4 units on a scaleStandard Deviation 7.6
Secondary

Exercise Motivation

Measured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of intrinsic and identified are better. Alternatively, low scores of introjected, extrinsic, and amotivation are better.

Time frame: Exercise motivation at the end of the 12 week intervention

ArmMeasureGroupValue (MEAN)Dispersion
PedometerExercise MotivationIntrinsic1.48 units on a scaleStandard Deviation 1
PedometerExercise MotivationExtrinsic0.49 units on a scaleStandard Deviation 0.69
PedometerExercise MotivationIdentified2.24 units on a scaleStandard Deviation 1.04
PedometerExercise MotivationAmotivation0.61 units on a scaleStandard Deviation 0.78
PedometerExercise MotivationIntrojected1.12 units on a scaleStandard Deviation 1.06
Electronic Activity MonitorExercise MotivationAmotivation0.15 units on a scaleStandard Deviation 0.38
Electronic Activity MonitorExercise MotivationIntrinsic2.84 units on a scaleStandard Deviation 0.77
Electronic Activity MonitorExercise MotivationIntrojected1.68 units on a scaleStandard Deviation 0.88
Electronic Activity MonitorExercise MotivationExtrinsic0.51 units on a scaleStandard Deviation 0.58
Electronic Activity MonitorExercise MotivationIdentified2.92 units on a scaleStandard Deviation 0.59
Secondary

Physical Function Measured by the Short Physical Performance Battery

Physical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled tandem balance.

Time frame: Physical function at the end of the 12 week intervention

ArmMeasureGroupValue (MEAN)Dispersion
PedometerPhysical Function Measured by the Short Physical Performance BatteryChair stand14.2 secondsStandard Deviation 3.7
PedometerPhysical Function Measured by the Short Physical Performance BatteryTandem balance9.2 secondsStandard Deviation 2.2
PedometerPhysical Function Measured by the Short Physical Performance Battery8 feet up and go5.9 secondsStandard Deviation 1.4
Electronic Activity MonitorPhysical Function Measured by the Short Physical Performance BatteryTandem balance9.1 secondsStandard Deviation 2.4
Electronic Activity MonitorPhysical Function Measured by the Short Physical Performance BatteryChair stand14.7 secondsStandard Deviation 5.5
Electronic Activity MonitorPhysical Function Measured by the Short Physical Performance Battery8 feet up and go6.4 secondsStandard Deviation 3
Secondary

Psychological Feelings

Measured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.

Time frame: Psychological feelings at the end of the 12 week intervention

ArmMeasureGroupValue (MEAN)Dispersion
PedometerPsychological FeelingsCompetence2.49 units on a scaleStandard Deviation 0.94
PedometerPsychological FeelingsAutonomy3.16 units on a scaleStandard Deviation 0.95
PedometerPsychological FeelingsRelatedness2.72 units on a scaleStandard Deviation 1.33
Electronic Activity MonitorPsychological FeelingsCompetence3.43 units on a scaleStandard Deviation 0.95
Electronic Activity MonitorPsychological FeelingsAutonomy4.01 units on a scaleStandard Deviation 0.95
Electronic Activity MonitorPsychological FeelingsRelatedness3.53 units on a scaleStandard Deviation 1.03
Secondary

Quality of Life Measured by the SF-36 Questionnaire

Sub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale.

Time frame: Quality of life at the end of the 12 week intervention

ArmMeasureGroupValue (MEAN)Dispersion
PedometerQuality of Life Measured by the SF-36 QuestionnairePhysical functioning62.3 units on a scaleStandard Deviation 29.3
PedometerQuality of Life Measured by the SF-36 QuestionnairePhysical role limitations67.9 units on a scaleStandard Deviation 26.6
PedometerQuality of Life Measured by the SF-36 QuestionnaireEnergy/vitality53.1 units on a scaleStandard Deviation 15.1
PedometerQuality of Life Measured by the SF-36 QuestionnaireEmotional role limitations75.8 units on a scaleStandard Deviation 25.5
PedometerQuality of Life Measured by the SF-36 QuestionnaireSocial functioning75.8 units on a scaleStandard Deviation 25.5
PedometerQuality of Life Measured by the SF-36 QuestionnairePain56.8 units on a scaleStandard Deviation 29.1
PedometerQuality of Life Measured by the SF-36 QuestionnaireMental health70 units on a scaleStandard Deviation 18.6
Electronic Activity MonitorQuality of Life Measured by the SF-36 QuestionnairePain60.3 units on a scaleStandard Deviation 26.1
Electronic Activity MonitorQuality of Life Measured by the SF-36 QuestionnaireMental health76.3 units on a scaleStandard Deviation 18.7
Electronic Activity MonitorQuality of Life Measured by the SF-36 QuestionnaireEnergy/vitality58.1 units on a scaleStandard Deviation 16.7
Electronic Activity MonitorQuality of Life Measured by the SF-36 QuestionnairePhysical functioning73.1 units on a scaleStandard Deviation 19.3
Electronic Activity MonitorQuality of Life Measured by the SF-36 QuestionnaireSocial functioning71.3 units on a scaleStandard Deviation 31.4
Electronic Activity MonitorQuality of Life Measured by the SF-36 QuestionnairePhysical role limitations72.2 units on a scaleStandard Deviation 24.2
Electronic Activity MonitorQuality of Life Measured by the SF-36 QuestionnaireEmotional role limitations71.3 units on a scaleStandard Deviation 31.4
Secondary

Resting Pulse

Time frame: Resting pulse at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
PedometerResting Pulse76.5 bpmStandard Deviation 11.9
Electronic Activity MonitorResting Pulse69.1 bpmStandard Deviation 14
Secondary

Waist-to-Hip Ratio

Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).

Time frame: Waist-to-hip ratio at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
PedometerWaist-to-Hip Ratio.84 ratioStandard Deviation 0.1
Electronic Activity MonitorWaist-to-Hip Ratio0.80 ratioStandard Deviation 0.1
Secondary

Weight

Time frame: Weight at the end of the 12 week intervention

ArmMeasureValue (MEAN)Dispersion
PedometerWeight86.8 kgStandard Deviation 13.6
Electronic Activity MonitorWeight81.9 kgStandard Deviation 11.2

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026